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In Brief This Week: Interpace Biosciences, 908 Devices, FDA, Quanterix, Co-Diagnostics, More

NEW YORK – Interpace Biosciences said this week that its fourth quarter revenues rose 24 percent year over year while its full-year 2023 revenues grew 26 percent from the previous year. For the three months ended Dec. 31, the Parsippany, New Jersey-based firm posted $10.3 million in revenues compared to $8.3 million the year before. It had a profit of $889,000, or $.20 per share, in Q4 2023 compared to a net loss of $1.6 million, or $.37 per share, in Q4 2022. For full-year 2023, revenues grew to $40.2 million from $31.8 million in 2022. Interpace posted a profit of $802,000, or $.18 per share, compared to a net loss of $22.0 million, or $5.18 per share, in 2022. The firm ended 2023 with $3.5 million in cash, cash equivalents, and restricted cash. 

908 Devices reported this week that its fourth quarter 2023 revenues climbed 23 percent year over year to $14.4 million from $11.6 million. The Boston-based firm said its installed base of handheld mass spec instruments grew to 2,853 devices by the end of the year with 139 devices placed during the fourth quarter. Its Q4 net loss declined to $7.4 million, or $.23 per share, from $9.8 million, or $.31 per share, in the year-ago quarter. For full-year 2023, the company's revenues climbed 7 percent to $50.2 million from $46.9 million in 2022. Its 2023 net loss climbed to $36.4 million, or $1.13 per share, from a net loss of $33.6 million, or $1.07 per share the year before. 908 finished the year with cash, cash equivalents, and marketable securities of $145.7 million. It expects 2024 revenue to be in the range of $52.0 million to $54.0 million. 

The US Food and Drug Administration has sent its final rule for regulation of laboratory-developed tests to the White House Office of Management and Budget in the Office of Information and Regulatory Affairs. The agency is expected to publish the final rule within the next several months, giving it oversight of LDTs.

Quanterix said this week that its Simoa Phospho-Tau 217 blood test has received breakthrough device designation from the US Food and Drug Administration as an aid in diagnostic evaluation of Alzheimer’s disease. The test is a semi-quantitative in vitro diagnostic immunoassay for the measurement of p-tau 217 concentration in plasma using Quanterix’s HD-X immunoassay system. Proposed indications include patients presenting with cognitive impairment who are being evaluated for AD risk to aid in diagnostic evaluation. 

Co-Diagnostics said this week that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance from the Central Drugs Standard Control Organization in India for its Saraplex Influenza multiplex test kit. The test can now be manufactured and sold to clinical laboratories as an in vitro diagnostic for the detection and differentiation of influenza A and influenza B. The test detects 13 strains of flu A and two strains of flu B and distinguishes H1N1 and H3N2. This is the 15th of CoSara's clinical lab tests to receive IVD clearance by the CDSCO. 

Cytek Biosciences said this week that it has opened a 50,000-square-foot facility in Wuxi, China. The new facility increases the cell analysis tools company's manufacturing capacity and houses operations, R&D, marketing, human resources, and sales teams for Cytek Wuxi. 

Australian diagnostics firm Proteomics International Laboratories said this week that it has successfully retained its ISO 13485 certification. The certification covers the design, development, production, storage and distribution, installation or servicing, and disposal of medical devices. 

Proteomics-based diagnostics firm Key Proteo said this week that it has begun construction of its CLIA-certified laboratory as it moves to commercialize newborn screening programs. The new 5,000-square-foot facility will be based in Seattle and will include a clinical laboratory alongside Key Proteo's corporate headquarters and clinical research facilities. Upon completion of the lab, the firm will offer a newborn screening panel targeting treatable genetic disorders, including Wilson's disease, Wiskott-Aldrich syndrome, X-linked a-y-globulinemia, and adenosine deaminase deficiency, Key Proteo said. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.